Inflatable implant

ABSTRACT

Described is an inflatable implant suitable for placement in the human body and left there for an indeterminate and potentially lengthy period of time. The implant is one that has a low profile when introduced into the body and a larger profile when it is inflated with one or more filler materials. Depending upon design and use choices the delivered implant may be removable and adjustable in situ in size, position, location, form, and rigidity. Indeed, in some variations, the design of the implant may be such that it may be removed at a potentially fairly lengthy time after implantation. The implant includes at least one bladder wall that generally is at least partially non-elastic (or unexpandable) after the preselected size is reached. The bladder wall will define at least one fillable volume and may form more than one independent fillable volumes. The bladder wall, in some variations, may be partially elastic or expandable to permit adjustment of implant size or configuration after or during delivery. The implant may be used as a supporting structure in a variety of differing body tissues and structures, e.g., in the spine or as a prosthetic in plastic surgery. The implant may also be used in conjunction with other components (often having a springed bias) as a source of movement in controlling the opening of a lumen or duct, that is to say, as a type of onoff valve or as a controlled flow valve. The implant may be used as an occludant within, or adjacent to, a variety of natural or abnormal anatomical body openings, e.g., vascular and genital lumina, aneurysms, ducts, septal defects, fistulae, esophagus, etc. The wall and filler material may be selected to deliver treatment materials the locale of the implant site or to remove amounts of harmful materials from such a region. The implant may, with an appropriate filler material or bladder wall material, be used in cooperation with an appropriate radio frequency (RF) source to cause the increase of a localized internal temperature and a resulting tissue change such as coagulation, ablation, or the like. Methods of using the implant are also described.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a Continuation of U.S. application Ser. No.12/628,623, filed Dec. 1, 2009, which is a Division of U.S. applicationSer. No. 10/461,853 filed on Jun. 13, 2003, the entire contents of eachof which are incorporated by reference herein.

FIELD OF THE INVENTION

This invention is in the field of surgery. In general, it is aninflatable implant suitable for placement in the human body and leftthere for an indeterminate and potentially lengthy period of time. Theimplant is one that has a low profile when introduced into the body anda larger profile when it is inflated with one or more filler materials.Depending upon design and use choices the delivered implant may beremovable and adjustable in situ in size, position, location, form, andrigidity. Indeed, in some variations, the design of the implant may besuch that it may be removed at a potentially fairly lengthy time afterimplantation. The implant includes at least one bladder wall thatgenerally is at least partially non-elastic (or unexpandable) after thepreselected size is reached. The bladder wall (or walls) will define atleast one fillable volume and may form more than one independentfillable volumes. The bladder wall, in some variations, may be partiallyelastic or expandable to permit adjustment of implant size orconfiguration after or during delivery. The implant may be used as asupporting structure in a variety of differing body tissues andstructures, e.g., in the spine or as a prosthetic in plastic surgery.The implant may also be used in conjunction with other components (oftenhaving a springed bias) as a source of movement in controlling theopening of a lumen or duct, that is to say, as a type of on-off valve oras a controlled flow valve. The implant may be used as an occludantwithin, or adjacent to, a variety of natural or abnormal anatomical bodyopenings, e.g., vascular and genital lumina, aneurysms, ducts, septaldefects, fistulae, esophagus, etc. The wall and filler material may beselected to deliver treatment materials to the locale of the implantsite or to remove amounts of harmful materials from such a region. Theimplant may, with an appropriate filler material or bladder wallmaterial, be used in cooperation with an appropriate radio frequency(RF) source to cause the increase of a localized internal temperatureand a resulting tissue change such as coagulation, ablation, or thelike. Methods of using the implant are also described.

BACKGROUND

Described is an inflatable, expandable implant suitable for implantationin a human body. In general, it is a device that may be implanted in thebody at a placement site in a lower profile form and expanded afterplacement. The implant may be used, for instance, to occlude or tosupport some region of the body.

The described implant may have a bladder with a substantiallynon-elastic bladder wall that defines a volume, and at least one bladderwall opening for introduction of filler material. In some examples ofthe implant, the bladder will have no passageway exterior to the bladderwall for passage of a body fluid from an end of the bladder to the otherend. The bladder may have at least one closure for each of the at leastone bladder wall openings. The closures operate to maintain the fillermaterial within the bladder after its introduction. If the fillermaterial is selected to be of the type that reacts in the bladder toform a non-flowing mass, a closure may not be necessary.

The use of occluding materials or implants over the past few years toocclude various areas in the body has expanded. For instance, intreating many vascular problems, the artificial blocking of blood flow,known generically as “embolization,” is used. The embolization of ablood vessel in an organ may be used to treat a variety of maladies;typically, though, embolization is used: 1) to control the bleedingcaused by trauma, 2) to prevent profuse blood loss during an operationrequiring dissection of blood vessels, 3) to obliterate a portion of ora whole organ having a tumor, or 4) to block the blood flow intoabnormal blood vessel structures such as arterio-venous malformations(AVM's) and aneurysms. For such treatments, a variety of mechanical andchemical occludants are available. Such occluding materials includeplatinum and stainless steel microcoils. Platinum microcoils sold asGuglielmi Detachable Coils (GDC) by Boston Scientific Corporation areeffective in many instances. However, significant skill is required tochoose a coil size proper for the malady prior to delivery. Manyanatomical sites are not suitable for use of microcoils, and removal isdifficult.

Other occludants include polyvinyl alcohol sponges (Ivalone) andcyanoacrylate glues (n-butyl and iso-butyl cyanoacrylates). Of these,the cyanoacrylate glues have an advantage over other embolic materialsin ease of delivery in that they are the only liquid embolics currentlyavailable to physicians. However, the constituent cyanoacrylate polymershave the disadvantage of being biodegradable. The degradation product,formaldehyde, is highly toxic to the neighboring tissues. See Vinters etal, “The Histotoxocity of Cyanoacrylate: a Selective Review”,Neuroradiology 1985; 27:279-291. Another disadvantage of cyanoacrylatematerials is that the polymer will adhere both to the blood vessel andto the tip of the catheter. Thus physicians must retract the catheterimmediately after injection of the cyanoacrylate embolic material orrisk adhesion of the cyanoacrylate and the catheter to the vessel.Removal and choice of occludant size are major problems.

Another class of liquid embolic materials, precipitative materials, wasinvented in late 1980's. See Sugawara et al, “Experimentalinvestigations concerning a new liquid embolization method: Combinedadministration of ethanol-estrogen and polyvinyl acetate”, Neuro MedChir (Tokyo) 1993; 33:71-76; Taki et al, “A new liquid material forembolization of arterio-venous malformations”, AJNR 1990:11:163-168;Mandai et al, “Direct Thrombosis of aneurysms with cellulose acetatepolymer. Part I: Results of thrombosis in experimental aneurysms.” J.Neurosurgery 1992; 77:497-500. These materials employ a differentmechanism in forming synthetic emboli than do the cyanoacrylate glues.Cyanoacrylate glues are monomeric and rapidly polymerize upon contactwith blood. Precipitative materials, on the other hand, arepre-polymerized chains that precipitate into an aggregate upon contactwith blood.

In the precipitation method, the polymer is dissolved in a solvent thatis miscible with blood, and upon contact with that blood, the solvent isdiluted and the water-insoluble polymer precipitates. Ideally, theprecipitate forms a solid mass and thus occludes the vessel.

The first such precipitative material used in this way was polyvinylacetate (PVAc). Also, poly(ethylene-co-vinyl alcohol) (EVAL) andcellulose acetate (CA) dissolved in 100% dimethyl sulfoxide (DMSO) havealso been used in clinical procedures. See Taki et al, “A new liquidmaterial for embolization of arteriovenous malformations”, AJNR 1990;11:163-168 and Mandai et al, “Direct thrombosis of aneurysms withcellulose polymer: Part I: Results of thrombosis in experimentalaneurysms”, J. Neurosurgery 1992; 77:497-500. Partially hydrolyzedpolyvinyl acetate in, e.g., ethanol, is also an available member of thisclass.

Each of these precipitative materials shares potential use problems inthat: (1) they introduce organic solvents into the body, materials thatcan damage microcapillary vessels and surrounding tissues and are alsoknown to cause vasospasm of blood vessels, and (2) placement of aprecipitating polymer and estimation of the resulting precipitated massis, at best, an inexact science.

The filled bladder implant described herein does not share any of theseproblems when used as an occluding device, may placed with betterprecision, and (when designed to do so) may be removed from theimplantation site.

SUMMARY

Described is an inflatable, expandable implant suitable for implantationin a human body. In general, it is a device that may be implanted in thebody at a placement site in a lower profile form and expanded afterplacement. The implant may be used to occlude fill or support someregion of the body.

The described implant may, in many examples of the implant, have abladder with a substantially non-elastic bladder wall that defines avolume, at least one bladder wall opening for introduction of fillermaterial. In many other examples of the implant, a bladder having anelastic bladder wall may be present. In some examples of the implant,the bladder will have no passageway exterior to the bladder wall forpassage of a body fluid from an end of the bladder to the other end. Thebladder may have at least one closure for each of the at least onebladder wall openings. The closures operate to maintain the fillermaterial within the bladder after its introduction. If the fillermaterial is selected to be of the type that reacts in the bladder toform a non-flowing mass, a closure may not be necessary.

The implant may be configured to achieve many results in a human body.For instance, the implant may be given a form that at least partiallycloses a body opening (and perhaps allows reopening of that lumen),e.g., a lumen such as a vascular lumen, genito-urinary lumen, bronchiallumen, gastrointestinal (G-I) lumen, or hepatic lumen, in a human bodyby placement or implantation in that body opening. This closing andopening may, depending upon the design, be controlled by the patient orby the physician. It may be of a type that simply provides additionalclosing force to a leaky fluid pathway but still allow the patient touse their own muscle tone to perform the step of opening the lumen.

The implant may, depending upon the design, be placed around, adjacentto, or within the lumen. The implant may be placed as desired in aregion where additional bulk is needed (e.g., in reconstructive surgery)or where some support is needed (e.g., in a joint such as the knee,spine, elbow, or wrist). The implant may take the form of a plurality ofhollow fibers or may have multiple chambers or may have a number ofdifferent wall materials, perhaps some elastic some not or all of one orthe other. Each chamber may have a separate filler and closure asneeded.

The implant may be designed to be removed at a later time. For instance,the implant may include a retrieving member, adapted to cooperate with aretriever, allowing removal of the implant from the body particularly byaccess of the retriever through the body lumen and removal through thatbody lumen. The retrieving member may be an integral portion of theimplant, that is to say that it is not separable from the implant oncedeployed, or it may be movable with respect to the rest of the implant.

The described implant may comprise the filler material. The fillermaterial may be a liquid, solid, gas, or other suitable form. It may beof a type that reacts to form a solid or gel in implant afterimplantation. The filler material may be a filling liquid, perhapsselected from the group consisting of water, saline, and biocompatibleliquids. It generally is to be flowable at implantation.

The filler material may contain a wide variety of ancillary materials.For instance, it may contain one or more radiopaque material, fluidssuch as those selected from the group consisting of iopromide,metrizamide, and their mixtures and solutions, and solids such as bariumsulfate, bismuth trioxide, and bismuth carbonate, and metals such astungsten, tantalum, gold, ruthenium, rhodium, osmium, iridium,palladium, platinum, rhenium, and their mixtures. The filler materialmay contain materials that absorb radio frequency energy. Such radiofrequency energy absorbing materials may be selected from the groupconsisting of iron oxides, iron hydroxides, graphite, and amorphouscarbon. Other ancillary materials are radioactive, bioactive, orchemi-active.

One desirable class of filler materials is a reactive mixture thatreacts within the bladder volume, such as, elastic solids, viscoelasticsolids, viscoelastic liquids, viscoelastic liquids comprising gelmicroparticles, viscous liquids, and their precursors. In particular,such materials comprise copolymers of a first member selected from thegroup consisting of poly(ethylene glycol), poly(ethylene oxide),poly(vinyl alcohol), poly(ethylene-co-vinyl alcohol), poly(acrylicacid), poly(ethylene-co-acrylic acid), poly(ethyloxazoline), poly(vinylpyrrolidone), poly(ethylene-co-vinyl pyrrolidone), poly(maleic acid),poly(ethylene-co-maleic acid), poly(acrylamide), and poly(ethyleneoxide)-co-poly(propylene oxide) block copolymers and a second memberhaving a strong nucleophile selected from the group consisting of athiol or a group containing a thiol.

Complementary mechanical ancillaries include one or more anchorsconfigured to maintain the implant in a selected position in the humanbody after introduction of a filler into the volume. They may be in theform of at least one anchoring region exterior to the bladder wall andconfigured to maintain the implant in a selected position in the humanbody after implantation, perhaps fixed to the bladder wall. Often suchan anchor, for example, a stent, is self-expanding upon deployment.Another mechanical ancillary includes at least one forming membersituated within the bladder volume and it is used to form a deployedbladder wall shape upon deployment. The forming member may variously beincluded in a form that is not to be removed after deployment, that isto be removed after deployment, or that is used in another function ortwo, e.g., to deflate the bladder or act as a catcher for a manipulableretriever to allow removal of an implant.

The bladder wall may be of a variety of materials, woven fabrics andnon-woven fabrics, perhaps of polymers such as at least one memberselected from the group consisting of polyethyleneterephthalate,polyvinylchloride, polyurethanes, polyolefins, polyamides, andfluoropolymers, perhaps at least one fluoropolymer selected from thegroup consisting of polytetrafluoroethylene,poly(ethylene-chlorofluoroethylene), poly (fluorinated ethylenepropylene), polychlorotrifluoroethylene, polyperfluoroalkoxy,polyvinylfluoride, polyvinylidenefluoride, and expandedpolytetrafluoroethylene (ePTFE). The material ePTFE is quite useful. Thebladder wall may also include materials such as carbon fiber, metalfiber, and alloy fiber where the task needs.

When the implant is used to heat a localized region within the body, atleast one of the bladder wall and the filler material comprises a radiofrequency energy absorbing material such as iron oxides, ironhydroxides, graphite, and amorphous carbon. Again the filler materialmay contain radiopaque material such as those discussed above.

One use for the implant is as a “valving assembly” used to control theflow of body fluids through a body tubular member lumen. The assemblymay be of a number of designs depending, e.g., upon the lumen to becontrolled. One such design, where the body lumen is normally closed(for instance, the urethra), closes the lumen, but can be adjusted orsized to permit the patient to use their own muscles to open the lumenagainst the added implant pressure. Such an assembly might be made up ofan implant member comprising an inflatable, expandable bladder with asubstantially non-elastic bladder wall defining a volume, having atleast one bladder wall opening for introduction of filler material, andat least one closure for each of the at least one bladder wall openings.Additionally, the implant might include a housing member having an openinterior, and a spring member (e.g., a bladder or spring). This exampleof the implant is installed around the lumen in such a way that thespring member is biased to close the body lumen by pressing the bodytubular member against the implant member. The implant member isinflatable with filler material to an amount allowing the lumen, incooperation with the spring member, to open upon introduction of bodyfluid pressure in the lumen (by the patient) and to close upon releaseof the pressure.

The valving assembly may include the filler materials and the ancillarymaterials discussed elsewhere herein.

Another valving assembly for controlling the flow of body fluids in alumen in a body tubular member may use a housing member having an openinterior and an implant member comprising an inflatable, expandablebladder that is at least partially elastic and having a bladder wall asthe controlling surface to close the lumen against the housing member.The overall elasticity of the bladder is adjustable upon implantation byfilling with a filler material in an amount appropriate to press thelumen closed against the housing member and to permit the lumen to openupon introduction of body fluid pressure in the lumen and to close uponrelease of the pressure. In another example of this variation, theimplant member is configured to allow movement of filler material into apartially elastic portion of the bladder during the introduction of bodyfluid pressure in the lumen.

A specifically controllable example of such a device is one in which theimplant member includes an inflatable, expandable bladder having asubstantially non-elastic bladder wall defining a volume, having atleast one motive section and a palpation reservoir hydraulicallyconnected to, but remote from, that at least one motive section. Whenthe palpation reservoir is squeezed, the motive section expands to movethe spring member, and to allow the lumen to open.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A shows a side, partial cutaway of a variation of our implant,collapsed and ready for introduction into the body.

FIG. 1B shows a side, partial cutaway of the implant of FIG. 1A afterinflation of the bladder with a filler material.

FIG. 1C shows the implant of FIGS. 1A and 1B after release of theimplant from the feed catheter.

FIG. 1D shows a cross section of the implant shown in FIG. 1A.

FIG. 2A shows a side view of another variation of the implant, ascollapsed for delivery.

FIG. 2B shows a side view of the implant of FIG. 2A after inflation.

FIG. 3A shows an end view of a substantially round implant.

FIG. 3B shows the implant of FIG. 3A in a side view.

FIG. 4A shows an end view of a long, tubular implant.

FIG. 4B shows a side view of the implant of FIG. 4A.

FIG. 5A shows an end view of a flat, panel-like implant.

FIG. 5B shows the implant of FIG. 5A in perspective view.

FIG. 5C shows a perspective view of an implant suitable for augmentationof soft tissue, e.g., the tissue in the chin.

FIG. 5D shows a perspective view of an implant having a support memberin the bladder wall.

FIG. 6 shows a partial cross-section of a horseshoe-shaped implant withdual filler material entrances.

FIGS. 7A, 7B, 7C, and 7D show, respectively: a deflated implant havingfillable hollow fibers as delivered to a treatment site, that deviceafter inflation, and that implant after release.

FIGS. 7E, 7F, 7G, and 7H show, respectively: a deflated implant havingfillable hollow fibers as delivered to a treatment site similar to thatshown in FIG. 7A but having a complex batten, that device afterinflation, that implant after release, and the delivery device and thebatten after removal from the implant, in the instance that the battenis removed.

FIG. 8 shows the inflation end of the implant shown in FIGS. 7A, 7B, and7C.

FIG. 9A shows an example of the implant shaped much like a sea urchin.

FIG. 9B shows a variation of the implant having dual inflation entrancesfor filler materials and using hollow fibrous sections in the bladderwall.

FIG. 9C is a partial cross-section of an implant having looped, fibrousportions in the implant.

FIGS. 10A, 10B, and 10C show, respectively, the placement of aplug-like, occlusive implant situated in an aneurysm mouth or throat,the implant ready to be delivered into the body, and the implant afterinflation.

FIGS. 10D and 10E show, respectively, a perspective and a sectional,side view of a plug-like, occlusive implant in a septal defect.

FIGS. 11A, 11B, and 11C show various components for fixating orimmobilizing the implant using respectively nubs, hooks, and a stent.

FIG. 12 shows the placement of a radiopaque band upon the implant.

FIGS. 13A, 13B, 13D, and 13F show longitudinal, sectional views of animplant that may be retrieved after delivery and the sequence involvedin placement and in retrieval.

FIGS. 13C and 13E are cross sectional views of FIGS. 13B and 13D,respectively.

FIGS. 14A-14C show longitudinal, sectional views of an implant that maybe retrieved after delivery and the sequence involved in placement andin retrieval. This example of our implant includes an integral site forretrieving the implant.

FIG. 15 shows a perspective view of a U-shaped implant that may beplaced about a human body's tubular lumen.

FIG. 16 shows in perspective, a generally helical implant forming asupport for a body tubular member or organ.

FIGS. 17A to 17C respectively show side view, end view andcross-sectional view of a multi-chambered implant.

FIG. 18 shows a valving assembly that may be used to close a human bodyduct or other bodily tubular member. This example of our implant is usedin coordination with a spring to hold the body lumen closed.

FIG. 19A shows a cross-section of the device found in FIG. 18 during the“relaxed” position.

FIG. 19B shows the body lumen open for movement of the bodily fluidthrough it.

FIGS. 20A, 20B, and 20C show a valving assembly utilizing an implanthaving one or more partially elastic sections that may be used incontrolling or stopping flow through a human body lumen.

FIGS. 21A, 21B, and 21C show a valving assembly utilizing an implantthat may be used in controlling or stopping flow through a human bodylumen. The implant is used to open the included valve and the lumen. Thedevice may be configured to be manually controlled by the user.

FIGS. 22A, 22B, and 22C show partial cutaway views of valves suitablefor use in allowing filler materials into the bladder volume.

DETAILED DESCRIPTION

FIGS. 1A, 1B, 1C and 1D show a typical implant made according to thisdescription, its major constituent parts, and (with the three Figurestaken together) show one way of utilizing the implant. FIG. 1A shows thefolded and pleated implant bladder (100) and its associated fillerdevice (102), e.g., a catheter, the opening (104) through bladder wall(106), and a closure or valve (108) situated, in this variation, in theopening (104) through bladder wall (106). The closure (108), in thisinstance, is a “duck bill” one-way valving mechanism that holds aflowable filler within the bladder (100) once it is inflated as shown inFIGS. 1B and 1C. To the right of in FIG. 1A is a cross-sectional view ofbladder (100) ready for implantation, showing the folding of the bladderwall (106) in a lobed configuration. Folding a fillable bladder in thisway allows the user to introduce the implant into fairly small placesand allows arrival of the implant and ease of placement in a fair hurry.In many instances when using platinum coils and the like as occlusivedevices, the length of the coils to be delivered is substantial. In someinstances, many linear feet of coils must be pushed through a catheterlumen to the site to be occluded. Occasionally, the length calculationis inaccurate. The coil may then be delivered before the realization ishad that the length of the coil is too long for the volume to beoccluded which leads to a remainder of the coil extending into, e.g.,the adjacent patent vessel. This implant allows in situ adjustment ofthe occludant size by controlling the amount of introduced fillermaterial.

FIG. 1B shows the bladder (100) after it has been inflated by fillermaterial (110). Filler material (110) expands the bladder wall (106) toa specific pre-chosen shape, past which the bladder (100) will expand nofurther. Bladder wall (106), in this example of the invention, includesa continuous non-elastic bladder wall (106) which in turn defines avolume (112) into which the filler material is pushed. In FIG. 1B, thefiller device (102) is shown to be inserted into the opening (104) inbladder wall (106) and the closure (108) is shown to be open as well.

It should be noted that unlike the endovascular grafts shown in U.S.Pat. No. 6,395,019, to Chobotov, the entirety of which patent isincorporated by reference, the implant of FIG. 1 and the othersdescribed herein, have no central passageway allowing passage of bodyfluid between its distal end (114) and its proximal end (116). Otherembodiments of the present invention, however, may have such a centralpassageway or similar conduit arranged in a different configuration asis explained in detail below.

FIG. 1C shows, in side view cross-section, the implant made up of thebladder (100), the bladder wall (106), filler material (110) occupyingbladder volume (112), and the closure (108) with its bills closed tomaintain the filler material (110) within volume (112) now that thebladder (100) has been inflated.

The materials of construction for various of these components aredescribed below in greater detail.

FIGS. 2A through 5B are examples of the wide variety of shapes intowhich the implant may be made. FIG. 2A shows an implant (140) having afolded a collapsed bladder (142) and filler introduction component (144)inserted into bladder (142). Bladder (142), as collapsed, may be quitesmall in diameter and length. FIG. 2B shows a side view of the implant(140) in which the bladder (142) has been expanded into a largedisk-like shape. Such a shape might be useful in treating anarterio-venous malformation.

FIG. 3A shows an end view of an additional example of a bladder implant(144). FIG. 3B, similarly, shows a side view of that substantiallyround, inflated bladder (146).

FIG. 4A shows an end view of a bladder (148) having a substantiallyround section. FIG. 4B shows, in side view, the tubular shape (150) ofthe bladder wall (150).

FIG. 5A provides an end view of bladder wall (152) and FIG. 5B shows aperspective view of that device (154). The implant (154) shown in FIGS.5A and 5B is generally flat, perhaps with the larger surfaces (156)ballooning a bit. An implant such as shown in FIGS. 5A and 5B might beused in plastic or reconstructive surgery in supplementing soft tissueshape, for instance, in re-shaping a chin or cheek.

Additionally, an implant having a shape such as that of implant (154)and designed to ultimately be removable from the body, may be placedbeneath a region of skin where the skin later is to be harvested for,e.g., burn treatment on a section of the body. The skin situated oversuch site is thereby expanded, increasing the available area of skin forthat later removal.

FIG. 5C shows a perspective view of a chin implant (157) having lobesthat expand upon inflation through inflation member (158). A designchoice is to be made here relating to the filler material used andtherefore whether a sealing valve of some type is needed in fillingmember (158). Since a chin implant may be soft to the touch, it may bedesirable to use a filling medium that does not polymerize (such as thetriglycerides of various saturated and unsaturated carboxylic acids oredible oils such as vegetable or nut oils) or one that polymerizes to agel-like consistency. In either case, some accommodation for holding thefilling medium in the volume defined by the bladder wall of chin implant(157) must be had. A one-way valve, perhaps of the design shownelsewhere herein, is one choice. A clamp on the filling member (158) issimilarly acceptable. If a polymerizable filler is used, a valvingmember might not be suitable. Similar considerations relating to thefilling devices are to be made for each of the devices disclosed here.

FIG. 5D shows an implant (161) similar in form to that shown in FIGS. 3Aand 3B. This Figure depicts a stabilizing element (163) situated in thebladder wall. The stabilizing element (163) depicted is a simple zigzagwire comprising, e.g., a superelastic alloy such as nitinol or astainless steel, and is intended to provide a measure of shape stabilityduring either, or both of, deployment or after final deployment. Avariety of such stabilizing elements coupled to the bladder wall forthis variation and others described here are acceptable for varioususes—braids, wires, ribbons, random fibers, woven fibers, etc. dependingupon the use to which the implant is placed.

FIG. 6 shows still another example of the implant (160). In thisvariation, the implant bladder wall (164) includes two passageways,respectively (166) and (168), and closures or valves associated witheach passageway. These openings (166, 168), of course, open into bladdervolume (162). The implant (162), in this example, is semi-circular. Ofcourse, the overall shape of implant (162) may be of any convenient arcsize, depending upon the service into which it is placed. That is to saythat the shape of implant (160) is not limited to a mere semi-circle,but instead may be any portion of a circle or, if such is needed, morethan a 360° loop with some overlap at the ends or even of a design thatwill follow any convenient curve. The cross-sectional shape may beelliptical or partially elliptical or oval or partially oval, indeed,any shape amenable to the introduction of a filler material into thebladder volume (162). The example shown in FIG. 6 is for the purpose ofexplaining and describing a variation in which more than one entrance tothe bladder volume is used and further describes a variation of theimplant in which a chosen bladder conformation is narrow at some pointin the interior volume. Flow problems potentially associated with such anarrow bladder configuration may be alleviated by introduction of afiller material to more than one point. Such a solution may alsoappropriate where the filler is visco-elastic or is some type of anon-Newtonian fluid. Additionally, depending, again, upon the serviceinto which the device is place, the medical treatment may requireinflation of one part of the bladder prior to inflation of another. Forinstance, use of a partially circular, oval, or semi-circular bladder inreplacement of or stabilization of a cervical disk might requireintroduction of filler from one specific end of the bladder.

An implant (160) having a structure such as shown in FIG. 6 may be usedto replace intervertebral disks or to augment herniated or degenerateddisks. Similarly, such an implant may be used to provide added “firming”structure to or to replace various bursa in and around the knee andelbow.

FIGS. 7A, 7B, 7C and 7D show a variation of the implant that utilizes anumber of fairly small tubular members as the bladder wall. Theresulting, inflated implant resembles a small fibrous ball or constructthat might, for instance, be used to occlude a vascular aneurysm.Because of its shape and very high surface area compared to its volume,it may also be suitable for delivery of medication or the like to thesurrounding region. One such instance would include construction of theimplant of a size adequate to remain in the human bladder afterplacement, having a medication in the filler material that is permeablethrough the bladder wall. Depending upon the filler and bladder wallmaterial chosen, the implant may be designed to be “self-passing” afterthe medication is depleted or be designed to be retrieved afterdepletion.

FIG. 7A shows a portion of a delivery device (200) with, e.g., adelivery catheter (202), having the implant (204) in collapsed conditionmounted at its distal extremity ready for delivery. Not shown, simplybecause of the size of the drawing, is the opening into themulti-hollow-fibered bladder wall (206).

FIG. 7B shows the expanded implant (204) and FIG. 7C the details ofbladder wall (206) in the blown up portion of the implant shown in FIG.7B.

FIG. 7D depicts the implant (204) after separation from the filler feeddevice (202).

As noted above, occluding devices of the shape shown in FIGS. 7A, 7B,and 7C, and 7D are very useful in occluding saccular aneurysms. Thereare a number of commercially available platinum-coil-based products thatare delivered through endovascular catheters specifically for thepurposes of: filling of such aneurysms, forming of a clot to occlude theaneurysm, and therefore preventing the aneurysm from rupturing orleaking with subsequent, perhaps catastrophic, results. When used in ananeurysm, our described implant is significantly easier to deliver in asize that is suitable for that aneurysm. That is to say, it is oftendifficult determine the length of platinum coil needed for properocclusion of the aneurysm. But, the use of our described implant allowsthe user to fill the implant only so much as is needed to inflate theimplant to a suitable size, all while observing (e.g., by fluoroscopy orultrasound or by other non- or minimally-invasive procedure) the size ofthe implant device during that filling step. Because our implant devicemay include thrombogenic materials on its surface and consequentlyavailable to the blood in the aneurysm, the device may provide a quickerresolution of an aneurysm than various other known devices andprocedures.

A device such as that shown in FIGS. 7A, 7B, 7C and 7D may be perceivedas having a potential problem with introducing filler into distantregions of the narrow bladder volume. Many highly desirable fillermaterials are viscous or have other nonlinear flow characteristics thatmake remote filling of the implant difficult. Consequently, a designerspecifying the dimensions of the implant and the composition of thefiller materials might choose any of a number of solutions to such aproblem. For instance, such a designer might choose a less viscousfiller material and utilize a catalyst or accelerator to gel the fillermaterial once the filler material is introduced into the bladder volume.Indeed, such polymerization catalysts and accelerators may be appliedinterior to, perhaps, a portion of the bladder wall. Other mechanicalflow-improving design procedures might include solutions such as areshown in FIGS. 9A, 9B, and 9C.

FIGS. 7E-7H show a variation of the implant system (212) in which theconcept of a removable “batten” or “template” is shown. The deflatedimplant (214), seen in FIG. 7E for this example, may be the same as thatseen in FIG. 7A except that the interior volume is adapted to allow thepresence of a multiple armed batten (216) (as seen in FIG. 7H). Thebatten (216) allows the user to manipulate the deflated implant (214)into a shape or position prior to inflation or, perhaps after fillingthe implant with filling material. FIG. 7F shows the implant (214) afterinflation with the filling material.

FIG. 7G shows the implant (214) after inflation with the fillingmaterial, withdrawal of the batten (216), and release from the fillingcatheter (202). Removable battens may be more complex or simpler inconfiguration than is shown as batten (216) depending upon the use. Sucha batten may be used with any variation shown here. In addition, batten(216) need not be removed but optionally may be left behind in implant(214). Batten (216) may consequently take on a different configurationthan that shown in FIGS. 7E-7H depending on whether it is intended to beremoved as shown or left behind in implant (214).

FIG. 8 shows one suitable simple introduction region (210) for devicessuch as are shown in FIGS. 7A, 7B, 7C and 7D. Incidentally, the inflatedsize of such an implant varies as needed by a particular indication suchas an aneurysm. For instance, it is typical that an aneurysm in thebrain is rarely much larger in diameter than one-half inch and normallynot much over a quarter-inch in average diameter.

FIG. 9A shows in partial cross-section an implant (250) where thebladder wall (252), once inflated, resembles a burr or vintage shippingmine. This device includes a central chamber (254) with a number ofopenings (256) extending out into the hollow “spikes” (258) providingthe significant surface area often desirable for forming thrombogenicsurfaces. The opening (260) into the bladder volume including centralvolume (254), is shown in a somewhat schematic fashion. In thisvariation, the filler material flows into the central chamber (254) andthen is faced with a number of flow paths into the tendrils extendingfrom that central section of the device. This enhanced number of flowpaths aids in permitting flow of these fluids into the spikes. It may beapparent to one of ordinary skill in this art that it would not benecessary that each of the “spikes” be hollow, but some may merely besolid appendages that, when the central chamber (254) is expanded willsimply extend radially outward. As noted above, it is within the scopeof this description that the interior of bladder wall (252), andparticularly in the region of the central chamber (254), be providedwith an accelerator for polymerization of multi-component precursorfiller material.

Again, a device such as this is very simple to introduce into a saccularaneurysm in, e.g. the vasculature of the brain, since the implant needbe placed only one time and filled.

FIG. 9B shows a conceptually similar solution to the problem ofproviding adequate flow paths for filler material where the implant isto have a large external surface area and a narrow bladder volume ornarrow volume sections. In this example, the implant (270) includesmultiple entries into the device bladder wall (272) and simply providesadditional flow paths to a downstream chamber (274) that, in turn, fillshollow fibrils (276). The hollow fibrils (278) emanating from theprimary bladder chamber (280) receive filler material only from feeddevice (282). The second chamber or portion of the bladder volume (274)receives filler material both from feed device (284) and from fillerdevice (282). Various sections of this example of the implant are shownto be separated in a somewhat exaggerated fashion. For instance, the twofiller supply devices (282) and (284) may be integrated into a singleshaft cooperating in shape with a two-port, single opening in thebladder wall utilizing bypass pathway (286) to secondary chamber (274).

Another variation of this solution is to loop the hollow fibers of theextended bladder wall. The narrow openings in the fibers are then filledfrom two ends at the same time. FIG. 9C shows a device (300) having acomplex interior volume made up of chamber (302) from which extend anumber of hollow fibers (304). Those fibers that are hollow and eachfiber lumen ends and begins at the bladder wall (306) surrounding volume(302).

As another non-limiting example of the versatility of the implantdescribed here, FIGS. 10A, 10B, and 10C show a variation of the implant(400) that may be used to close the neck of a small-neck aneurysm (402).The shape of implant (400) and its placement in the neck of aneurysm(400) are shown in FIG. 10A. Such an implant form may be used by itselfto close such aneurysms or used in conjunction with other occlusivedevices placed previously in the aneurysm. FIG. 10B shows the implant(400) with its deflated shape, prior to introduction into the treatmentsite, and attached to a delivery catheter which, in this instance,serves as a filler material delivery device. In FIG. 10C, implant (400)has been expanded to show its shape prior to removal of the fillermaterial delivery device (404).

An implant having an appropriate shape such as found in FIGS. 10A-10Cmay similarly be used to repair interventricular septal defects. FIGS.10D and 10E show placement of an implant (406) into an opening in themuscular interventricular wall (408). Delivery may be viacatheterization procedures well known in interventional cardiology.

The set of implants exemplified above, demonstrate the facility andversatility with which this concept may be applied to a large number ofbody sites, particularly where an interior opening, be that opening alumen, a sac, a duct, or an os, is to be filled, supported, or treated.

When our implants are used to occlude, they may be used in cooperationwith ancillary components to assist in their function of occlusion. Forinstance, FIGS. 11A, 11B, and 11C show various ways of immobilizing orfixating the implant at a site to be occluded. Again, these are butexamples of the generic concept of immobilizing or fixating the implantwhere an implant designer choosing or completing a specific designutilizes the teachings here to make a specific device forimplementation.

FIG. 11A shows a partial sectional view of an implant (450) having abladder wall (452) and a band of nubs (454) situated on the exterior.The nubs (454) are intended to engage the wall of a lumen or the likeupon inflation of the implant in the body.

Similarly, FIG. 11B shows an implant (456) having a stent-like component(458) that includes a number of hooks (460) or barbs designed to engagea wall of lumen to which the device (456) was placed. The stent-likecomponent (458) may also provide some additional structure support tothe device (456) and may aid in filling the implant with fillermaterial.

FIG. 11C shows another example of the device (456) having a stent-likestructure (468) deployed on the exterior of a bladder wall (470). Inthis variation, as was the case with the variation shown in FIG. 12, thestent-like structure may be self-expanding upon deployment and beproduced of a material such as a suitable stainless steel, a superelastic alloy such as nitinol, or any other material that is appropriatefor this particular task. Similarly, the stent-like structures may be ofa type that are expanded by the introduction of filler material into thebladder volume within the bladder wall (470) and may be simply malleableenough to maintain their shape at deployment. These structures may beused to provide stability to the desired shape of the implant afterdeployment.

Another desirable ancillary component is a radiopaque marker mounted onthe bladder wall (482) of implant device (484). A marker such asradiopaque band (480) permits a medical professional accurately to placea device within the human body and, once so-placed, identify at a latertime whether the device is still situated properly. Although theradiopaque band (480) depicted in FIG. 12 is shown to be circumferentialand near an end of an implant, a designer may obviously placeappropriate radiopaque markings at any suitable place on a device madeaccording to these teachings. Such markings may aid or assist in properplacement, inflation, identification of the device, or whatever otherfunction is then desired.

Other ways to provide or impart radiopacity to the implant include, forinstance, placement (perhaps by ion-sputtering) of a radiopaque materialsuch as gold onto the implant, including a powdered radiopaque solidsuch as barium sulfate in polymer of the bladder wall, or byintroduction of a radiopaque dye into the bladder wall.

FIGS. 13A-13F show an implant (486) that is designed to be implanted inand to occlude a lumen such as a Fallopian tube or vas deferens, andthen to be optionally removed. These drawings also show a deliveryarrangement that may be used with many of the implant variationsdescribed here, in which a sheath is used over the implant duringdelivery and removed during deployment.

FIG. 13A shows an implant (486) having a support and retrieval wire ormember (487) and a fill valve region (488). The implant (486) is coveredby sheath (489) for delivery. A fill tube (490) is in the fill valveregion (488) of the implant (486). Finally, a safety wire (492) having apigtail end (494) located within the lumen of fill tube (490) is shownholding the implant (486) in place until deployment is desired.

FIG. 13B shows the pullback of the sheath (489), the movement of thefiller material (493) through fill tube (490) and fill valve region(488) into the implant (486). The safety wire (492) has been rotated andhas disengaged from support and retrieval wire (487). The support andretrieval wire (487) may be of a looping design that allows it to expandupon release of the sheath (489) and provide a measure of form to theimplant and of seal force against the vessel (494) wall. The support andretrieval wire may have a section extending outside of the interiorimplant volume. FIG. 13C shows the inflating implant within the vessel(494) wall and the fill valve region (488) still open and acceptingfiller material.

FIGS. 13D and 13E show fill tube (490) having withdrawn from fill valveregion (488) and support and retrieval wire (487) expanded to its fullsize within the implant (486) volume. FIG. 13E shows implant (486) fullyexpanded against the vessel (494) wall and closure of the fill valveregion (488) over the support and retrieval wire (487). The implant isfully functional as an occluder in FIGS. 13D and 13E.

FIG. 13F shows removal or retrieval of implant (486). A retriever tube(495) having a retriever (496) has been introduced into the vessel (494)and the retriever (496) twisted to engage the support and retrieval wire(487). Proximal movement of the retriever (496) either moves the implant(486) or moves the support and retrieval (487) wire collapsing the loopsof the support and retrieval wire (487) into the fill valve region (488)allowing the biocompatible filler to escape. All of this collapses andloosens the fit of the implant (486) within the lumen allowing it tofollow the retriever tube (495) and the retriever (496) out of thevessel.

FIGS. 14A-14C show longitudinal, sectional views of an implant that maybe retrieved after delivery, the use of integral retrieval sites in theimplant, and the sequence involved in placement and in retrieval.

FIG. 14A shows an implant (501) that has been introduced into the lumenof a tubular member (520) of the body. An optional retractable sleeve(502) is situated outside of the implant (501). The implant (501) ismounted distally on a delivery member (503). A filler-retainer member(504) having extensions (505) that pass through openings (506) in thedistal end of implant (501) is also shown. The distal-most end offiller-retainer member (504) also is shown passing through theillustrated fill valve and closure (507) situated in the implant (501).The filler-retainer member (504) in this example of the implant assemblyhas the functions of holding the implant (501) in place by interferenceof the extensions (505) in openings (506) during the step of placementat the treatment site, of holding the implant (501) in place at the endof the delivery member (503) during the filling step (after the optionalouter sleeve (502) has been withdrawn), and of acting as a passagewayfor the filling materials (508) during expansion of the implant (501)bladder.

FIG. 14B shows the implant (501) in place acting as an occluding memberin the vessel (520) with the filler material (508) within the volumeinside. The various openings (506) acting as integral retrieval sitesare shown. Previously, the optional retractable sleeve (502) has beenretracted, the filler-retainer member (504) has been withdrawn allowingextensions (505) to pull from openings (506), and the delivery member(503) has also been retracted. Each of optional retractable sleeve(502), the filler-retainer member (504), and delivery member (503)extend to the users' end and typically would be independentlymanipulable.

FIG. 14C shows a typical way of removing implant (501) using a retriever(510) that cooperates with the openings (506) to grasp or otherwisesecure the implant (501) to the retriever member (510) via engagement ofthe extensions (511) into the openings (506). In this example of theimplant assembly, the retriever (510) also acts to bleed the fillermaterial from the implant (501) interior volume. An exterior sleeve(512) may also be used to center the end of implant (501), if sodesired.

As we have mentioned elsewhere, these implants may be used to performthe function of occluding openings in the body when they are placedwithin the opening. Additionally, our implant may be used to control orto close tubular passageways or ducts by squeezing those openings fromthe exterior of those tubular passageways. For instance, in addition tothe fallopian tube closure shown just above, a sterilization proceduremay be performed by placement of an implant on the exterior of the tubein such a way as to close the tube. The versatility of our implant issuch that (depending upon the use and design) it may be used as apermanent closure device for such body structures, as a temporary (butlater removable) closure, or as a component of devices that controlpassage through a body passageway under the control of the patient ortheir physician.

FIG. 15 shows one method of occluding, or narrowing or controlling thesize of a lumen in a tubular body member (520) using, in this instance,a loop-shaped bladder (540), that when inflated, will close the lumen(500) or narrow it depending upon the physical size of the implant (522)and the extent to which it is inflated. Shown attached to this exampleof the implant are tie lines (524) that may be used to secure theimplant (522) to a nearby anatomic structures, perhaps when the implant(522) is used as a sling in assisting urethral control. Similarly, thetie-lines (524) may be used to secure the implant (522) onto the bodytubular member (520).

FIG. 16 shows another variation of the implant (530) having a simplehelical shape. Since the implant (530) may be filled with fillermaterial that is in situ polymerizable into a gel or even into a solid,the implant (530) may be filled, the filler material cured or hardenedwhile being held in place, and the resulting structure used as anexterior supporting structure for the lumen or as a stabilizer structurefor the tubular body member, perhaps in conjunction with an aneurysm.Bladder wall (532) is also shown in the FIG. 16.

FIGS. 17A and 17B depict side and end views of an implant (540) havingmultiple independent bladder or bladder volumes. The shape depicted inFIGS. 17A and 17B may be used in those situations where an additionalmeasure of turgor or support is needed, for instance, at a sphinctermuscle controlling a bodily fluid flow or direction. This implant may beused (with proper sizing and adjustment of the respective bladdercompositions, etc.) in treating such maladies as gastroesophageal refluxdisease (GERD) and severe female urinary incontinence (FUI). FIG. 17Ashows an inner bladder (542) and an outer bladder (544). In thisvariation of the multiple bladder implant, the bladders share a wall,the outer bladder (544) is intended to enclose a settable or curablefiller material, the inner bladder (542) is intended to enclose a fillermaterial that remains fluid or gel-like after introduction. Thisvariation also exemplifies, for the scope of described implants foundhere, the generic application of elastic bladder walls, comprisingelastomeric materials or other similarly expandable materials, inconjunction with bladder walls that are not elastic—at least as theconcept of inelasticity is used in the medical device area. Forinstance, angioplasty balloons are often made of materials such asNylon. When expanded, those balloons expand to a specific diameter, butnot more. Nylon is considered to be inelastic in a practical sense forthose purposes.

In any case and for the purposes of this example, the implant (540) maybe constructed with an outer bladder (544) of an inelastic material andan inner bladder (542) comprising an elastic material. Often, treatmentof severe instances of diseases such as GERD entail the surgicaladdition of a muscle structure to the offending sphincter musclestructure. From an engineering viewpoint, the added muscle does notprovide significant added strength. The multi chambered “clip” shapedimplant (540) shown in FIGS. 17A, 17B, and 17C can be constructed toprovide a firm assist to the sphincter muscle structures without majorsurgical intervention. The outer bladder (544) provides flexing strengthby compression of the region between the two opposing sections or armsof the bladder. The inner bladder (542) may be provided with a compliantinner surface (548) by use of both of (or, either of) an elasticmaterial and a non-setting filler, e.g., a gel or liquid. The inwardpressure onto the surface (548) may therefore be adjusted in manycomplementary ways.

FIG. 17C shows a cross-section of the implant (540) with the outerbladder (544), the inner bladder (542), and the fill valves (inner 550,outer 552). A filler member (554) is also depicted that may be used toindependently fill the two bladders.

FIGS. 18, 19A, and 19B show the use of the implant as a source of motionor pressure for controlling a valve assembly that may be placed in thehuman body, for instance, in treating GERD or FUI using activemanipulation. The operating concept of the depicted valving device (600)is that the tubular member (602) is typically closed due to the forcesexerted upon it by the flexible, perhaps springy, housing (604) and bythe spring member (606) bias. In this instance the inventive implant(608) is used to “tune” the residual pressure placed against the tubularbody member having the lumen. In one example of this valving assembly(600), the overall pressure of the depicted spring (through the tubularbody member) against the implant is selected so that the person intowhom this device is implanted is able to urge or push fluids through thetubing using their own muscles. For instance, in assisting with controlof urinary voiding, the stiffness of the housing (604), the springmember (606) and the amount of filler material introduced into implant(608) are chosen, after testing of the patient, so that he or she canpush urine past this valving assembly using typical abdominal muscles.FIG. 19A shows a cross section of the valving assembly (600) shown inFIG. 18 during the time the tubular body member (602) is closed by avalving assembly (600). It may be noted that the upper and lowerportions of housing assembly (604) are shown to be separable. Althoughthis is not a necessity, it is convenient for installation and laterremoval if muscle vigor of the patient declines with time. Otherconvenient spring and housing arrangements would be apparent upon thisdescription. Similarly other sources of spring bias or springiness,e.g., balloons or other internal organs, may also be used in thisdevice. Bladder volume (606) and bladder wall (608) are shown ascooperating with the spring member and body (604) to close the lumenshown there.

FIG. 19B shows the opening of lumen (610) by, e.g., the implantee'smovement of fluid via increased pressure through that lumen (610). Whenthe patient so voids, the spring member (606) flexes in the direction(612) and the flexible housing flexes inward in the directions noted byarrows (614) and (616). When the pressure in lumen (610) ceases, thevalving mechanism (600) returns to the state found in FIG. 19A.

FIGS. 20A, 20B, and 20C show another variation of a valving assemblyusing our implant. In this example, the implant includes both inelasticand elastic components in communication with the filler material. FIG.20A shows a body tubular member (632) surrounded by a ring or housingmember (634) having an open center, which ring member (634) may beelastic or more likely, inelastic. Situated within the ring is aninelastic portion (636) of the implant (630). The implant (630) isfilled with a filler material that is sufficiently mobile, perhapsfluid, so that a slight pressure is placed by the bladder wall (636)against the body tubular member (632) to maintain closure of the bodylumen. However, as was the case with the implant shown in FIGS. 18, 19A,and 19B, the patient may urge his bodily fluids through the body tubularmember (632). When this happens, the portion of the implant (630)beneath the ring is compressed and filler material flows into theelastic sections (638) of the device (630). The movement of the exteriorwall of the implant (630) is shown to be moved at arrows (640); such amovement allows the patient's body tubular member to open and fluids toflow. When the pressure interior to that lumen within the body tubularmember (632) is relaxed, filler material within the elastic sections(638) will return to the region beneath ring (634) and the wallcontacting the tubular member (632) will press against that body memberin the directions shown by arrows (642) and close the interior bodylumen.

Another use of our implant is shown in the valving assembly shown inFIGS. 21A, 21B, and 21C. In this example, the implant (650) is used tomove a spring member biased to close a body lumen to a position wherethe body lumen is open by manipulation of, or palpation of a portion ofthe implant.

FIG. 21A shows the major components of the valving assembly. The implant(650) is shown in FIG. 21A with a palpation reservoir or bulb (652) atone end of the device and with a pair of expandable fingers (654) (or,generically, “motive sections”) at the other extremity of the implant.This example is shown with two fingers (654) and, as will be explainedbelow, during placement and use of the device it is necessary in thisvariation that the fingers be held in such a way to be spaced apart fromeach other. Otherwise, during a filling operation, the fingers will movetogether and squeeze the involved body duct. Other suitable arrangementsusing a single finger or more than two fingers would be apparent uponsimple reflection. FIG. 21A also shows the housing spring subassembly(656). This is made up of a housing member (658) and a biased spring(660). The body tubular member (662) that is to be under control by thisdevice is also shown.

The implant (650) in this variation is not to be filled to its maximumpossible volume if inelastic bladder wall materials are to be used. Thesizes, volumes, filler material/fluids, should be selected in such a waythat when the palpation bulb (652) is squeezed, the fingers (652) areable to expand and move the spring away from the body tubular member.

FIG. 21B shows a partial perspective cutaway of the “normal” ornon-actuated or resting state of the device after implantation. Itshould be noted that although we have chosen not to show the housingmember (658) with a seam or other way to place the body (658) about thebody tubular member (662) some manner of placing the housing about thebody tubular member (662) is necessary. Other designs, perhaps using a“U” shaped housing would not be so constrained.

FIG. 21B shows the housing member (658) and the spring member (660)biased downward to squeeze the body tubular member (662) to close itslumen (664). Also shown are the two fingers (654) of the implant (650).As was the case in discussing the device found in FIGS. 18, 19A, and19B, housing member (658) may be stiff or, more likely may be somewhatspringy. A biocompatible, elastomeric material would be appropriate forthis part. Interior to housing member (658) may be seen spring member(660). Spring member (660) is a biased downward and made of materialthat may be moved by inflation of fingers (654).

FIG. 21C shows the desired action of the inflation of fingers (654) tomove spring member (660) upward and allow the opening of body lumen(664). Upon release of the pressure on the palpation bulb (652), thespring (660) should relax into the position found in FIG. 21B and closelumen (664).

The assembly shown in FIGS. 21A, 21B, and 21C is to be placed within thebody using a surgical procedure. The bulb (652) may be placed in such aposition that it can be manipulated by the person into whom the implanthas been placed using, for instance, the strength in a hand to open thevalve assembly. For instance, where the implant shown in FIGS. 21A, 21B,and 21C is to be used for bladder control, the palpation bulb would bedesirably placed beneath the skin of the lower abdomen at a site wherethe bulb (652) would not be easily bumped nor would it be squeezed uponnormal clothing binds or the like. The size of the bulb (652) in such asituation need not be very large in that little fluid would need to bemoved, in turn, to move the spring releasing the urethra.

Bladder Wall Materials

To allow selection of a desired controllable size for the implant wherethe size need not be adjusted after introduction into the body, thebladder wall material may be non-elastic and of a biocompatible fabric.In many instances, the implant designer using the teachings found herewill choose to form the implant from a single material. Suitablepolymers that are formable into continuous structures or forms (e.g.,sheets, tubes, etc.), fabrics (woven and non-woven), and ancillarycomponents, e.g., portions of the valving, and that are biocompatiblysuitable as long term implants, are currently but a few:polyethyleneterephthalate (PET or “Dacron”), polyvinylchloride (PVC),various polyurethanes, polyolefins (various polyethylenes,polypropylenes, polybutylenes, and random and block copolymers), variouspolyamides (in particular, the Nylons), and fluoropolymers (such aspolytetrafluoroethylene (PTFE or TFE), poly(ethylene-chlorofluoroethylene) (ECTFE), poly(fluorinated ethylenepropylene) (FEP), polychlorotrifluoroethylene (PCTFE),polyperfluoroalkoxy (PFA), polyvinylfluoride (PVF) orpolyvinylidenefluoride (PVDF)), and porous and expandedpolytetrafluoroethylene (ePTFE).

The materials most widely currently used for implants, such as syntheticvascular grafts, are likely PET in the form of Dacron® and ePTFE in theform of ImpraGraft® and Goretex®. Those materials similarly suitable formany of the uses contemplated here. The current medical experience withthese materials allows the designer to make an appropriate materialsselection for an intended use. For instance, in the implantsspecifically designed for later removal or designed for potential laterremoval, such as those used in semi-permanent birth control, forinstance, as an occlusive sterilizing plug to be situated in theFallopian tube or vas deferens, a material having a physical structure,e.g., microstructure, with very low permeability to the ingrowth of theneighboring tissue would be a good selection. Similarly, implants usedfor filling vascular aneurysms desirably are constructed of materialshaving a significant potential for tissue ingrowth.

In those variations of the described implant where the filler materialacts as a “sink” or reservoir of a treatment material of some kind,e.g., medication, anesthetic, analgesic, antibiotic, biologic, etc., abladder wall material should be chosen having an appropriatepermeability and thickness allowing release of that treatment materialat the chosen site. The variations in which the implant is used forretention of ill-actors, such as trace metals, criteria for selectingthe bladder wall material should include at least its ability to allowpassage of the bad actor to the filler material.

When the bladder is used as a radio frequency energy sink (as discussedbelow), some amount of carbon fiber, e.g., pyrolyzed polyacrylonitrileor the like, or other radio-frequency absorbing materials such as metalor alloy fibers, may comprise the bladder wall, or be added to the mixof materials making up the bladder wall or be made adherent to thebladder wall in the region where desired.

The use of combination or laminated bladder wall materials is alsocontemplated. For instance, use of an elastomeric or rubbery material(sheets, non-continuous regions, etc.) exterior to the substantiallynon-elastic bladder wall material as a method of anchoring or otherwisemaintaining the implant in position is suitable. Addition of a porous orfibrous material, e.g., PET and mixtures of other fibers, on theexterior of a bladder wall selected for use in a vascular environment,for the specific purpose of promoting angiogenesis or thrombogenesis, isalso within the scope of the technology disclosed here.

Finally, it is with in the scope of this invention that the bladder wallinclude independent regions of elastic materials, e.g., polyurethanes,polycarbonate urethanes, an elastomeric silicone materials in additionto the wall components of inelastic material.

Inflation Components

Introduction of a filler material into the bladder volume may beaccomplished in a wide variety of ways and using any number of differentcomponents to pass the filler materials, e.g., fluid (or fluids),through the bladder wall and into the bladder volume. For instance, whenprecursor materials that are reactive in situ to set, or to form a gelor solid in the bladder volume over time are introduced into thatvolume, the chosen introducer device may simply be held in place to forma plug until the reaction is sufficiently complete and the gel or solidis extant. A simple opening in the bladder wall serves, in cooperationwith the introducer, to maintain the filler in the bladder volume.

Normally, though, one or more optional one-way valves form thepassageway through the bladder wall permitting flow into the interiorbladder volume and preventing filler material flow out of the volumeonce either the bladder volume is filled or the introducer device isremoved from the one way valves. FIGS. 22A, 22B, and 22C provideexamples of such optional valves.

FIG. 22A is a longitudinal cross-sectional view of a spring-loadedinflation valve. The one-way inflation valve (700) has an outer wall(702), an inner lumen (704), an annular spring stop (706), an annularball seal (708), a sealing body (710), and a sealing spring (712). Theconfiguration depicted in FIG. 22A allows for introduction of a fillermaterial in the direction of the arrow (714) while preventing its exitonce pressure is removed.

FIG. 22B illustrates a duckbill-type one way valve. This exemplifiedone-way inflation valve (720) has an outer wall (722), an inner lumen(724), a first duckbill valve surface (726), and a second duckbill valvesurface (728). The two bill surfaces are biased towards and seal againsteach other when the introduction device is removed and the valveassembly is relaxed. The valve depicted in FIG. 22B allows for movementof the filler material in the direction of the arrow (730) whilepreventing its exit once pressure is removed.

FIG. 22C illustrates an example of an insertable seal (740), operatingmuch in the same way as does a wine cork, but one that cannot later beremoved by normal means. The seal has an outer wall (742), an innerlumen (744), a plug (746), and a sealing surface (748). The plug (746)has a sealing head (750) which sealingly engages the sealing surface(748) by irreversible deployment during application of force to the plug(746) in the direction of the arrow (752).

Filler Materials

The bladder may be filled with a filler material, a convenientbiocompatible material, that may be wide-ranging in nature. It may be agas, if so desired, although in most circumstances, the filler may be aliquid, gel, or slurry. Convenient filler fluids include water, saline,and other fluids or gels such as those commonly employed in implants.Such biocompatible materials include triglycerides, (e.g., peanut oils),salts of chondroitin sulfate, salts of hyaluronic acid, variouspolyacrylamide compositions, various polysaccharides,hydroxypropylmethylcellulose polymers, and mixtures. Patient bodyfluids, e.g., blood, may be useful as filler materials in somecircumstances.

As to other forms of the filler material: we have also had excellentexperience with polymeric biomaterials, specifically polymerichydrogels, that were specifically developed for medical treatments. Theyare of the type shown in WO 00/44808, to Hubbell et al, published Aug.8, 2000, the entirety of which is incorporated by notice. Thesematerials are made via addition reactions between a strong nucleophileand a conjugated unsaturation, for polymerizing or cross-linking two ormore components in a manner that can be accomplished even in thepresence of sensitive biological materials. Such reactions include theformation of biomaterials in the presence of drugs, including proteinsand DNA, formation of biomaterials in the presence of cells and cellaggregates, and also formation of biomaterials in vivo variously, withinthe body, upon the surface of the body, or in a bladder as describedabove. It is possible to form these biomaterials in the presence ofsensitive biological materials because of the high self-selectivity ofthe addition reactions between strong nucleophiles and conjugatedunsaturations, that are employed. A strong nucleophile of particularinterest in the method described herein is the thiol.

The formation of the noted biomaterial in the presence of the sensitivebiological materials involves mixing two or more liquid components andreacting them to form an elastic solid, an inelastic solid, aviscoelastic solid (similar in consistency to a gel such as gelatin), aviscoelastic liquid (similar to a gel that can be induced to flow, forexample, a petroleum jelly), a viscoelastic liquid that is formed of gelmicroparticles (such as a “Carbopol” gel), or even a viscous liquid of aconsiderably higher viscosity than either of the two precursorcomponents. The chemical conversion from the precursors to the finalmaterial is sufficiently selective that it can be carried out in thepresence of sensitive biological material without substantial sidereactions, including the instance where the biological material is thebody itself.

One family of such synthetic polymers may: (i.) be converted from liquidprecursors to polymeric linear or cross-linked biomaterials prior toimplantation or in situ at a site of implantation; (ii) be hydrogels ormore substantially non-swelling materials; (iii) present bioactivemolecules that serve as adhesion sites, to provide traction for cellinvasion; (iv) present bioactive molecules that serve as proteasesubstrate sites, to make the material degrade in response to enzymes(e.g., to collagenase or plasmin, that are produced by cells during cellmigration); (v) present growth factor binding sites, and (vi) providefor the delivery of protein drugs by hydrolysis or enzymatic degradationof groups contained within the polymers forming the gel.

One variation of a method for forming a biomaterial, perhaps degradable,involves combining two or more precursor components of the biomaterialunder conditions that allow polymerization of the two components, wherepolymerization occurs through self selective reaction between a strongnucleophile and a conjugated unsaturated bond or a conjugatedunsaturated group, by nucleophilic addition. The functionality of eachcomponent is at least two, and the biomaterial does not compriseunprocessed albumin. In addition, the conjugated unsaturated bond orgroup is not a maleimide or a vinyl sulfone.

For instance, the components may be selected from the group consistingof oligomers, polymers, biosynthetic proteins or peptides,naturally-occurring peptides or proteins, processed naturally-occurringpeptides or proteins, and polysaccharides. Of these, the polymer may bepoly(ethylene glycol), poly(ethylene oxide), poly(vinyl alcohol),poly(ethylene-co-vinyl alcohol), poly(acrylic acid),poly(ethylene-co-acrylic acid), poly(ethyloxazoline), poly(vinylpyrrolidone), poly(ethylene-co-vinyl pyrrolidone), poly(maleic acid),poly(ethylene-co-maleic acid), poly(acrylamide), or poly(ethyleneoxide)-co-poly(propylene oxide) block copolymers.

The peptides may, for instance, comprise an adhesion site, growth factorbinding site, or protease binding site.

In another variation, the components may be functionalized to comprise astrong nucleophile or a conjugated unsaturated group or a conjugatedunsaturated bond. In this variation, the strong nucleophile may be agroup such as a thiol or a group containing a thiol and the conjugatedunsaturated group may be an acrylate, an acrylamide, a quinone, or avinylpyridinium, for example, 2- or 4-vinylpyridinium. Either of thecomponents may have a functionality of two, three, or more.

In some variations where acceleration of the reaction to form a gel isdesirable, an accelerator may be added prior to polymerization. Forinstance, mixing of the precursor components with a component having atleast one conjugated unsaturated bond or conjugated unsaturated groupand at least one amine reactive group will accelerate thepolymerization. Where cells are to be added to the resultant mixture,that accelerator may also be applied to the cell surface site ofpolymerization.

Where the biomaterial is used to deliver a therapeutic substance, e.g.,one or more selected from the group consisting of proteins, naturallyoccurring or synthetic organic molecules, nucleic acid molecules, forexample DNA or RNA, and a viral particle, prodrug, or nucleic acidmolecule such as antisense nucleic acid molecules, the precursors may bereacted in those therapeutic substance's presence.

These exemplified materials may be formed in situ by simple addition ofthe reactants or precursors to the delivery device, e.g., a catheter,with or without an accelerator, and moving them to the implant for finalreaction.

In addition to the filler materials that are placed in the bladder to“fill out the form” so to speak, additional materials may be placed inthe bladder volume to allow visibility or detectabliity of the bladdershape or location. For instance, radiopaque materials allow visibilityin fluoroscopes. Other types of opacifiers enhance detectability using,e.g., ultrasound.

Suitable and widely used liquid radiopacifiers include metrizamide (seeU.S. Pat. No. 3,701,771) and iopromide (see U.S. Pat. No. 4,364,921).Metrizamide is sold in a dilute form as “Amipaque” by Winthrop-BreonLaboratories, a division of Sterling Drug Inc. Iopromide is often soldin a dilute form under the tradename “Ultravist”. Other radiopaqueliquid radiopacifiers are known.

Suitable solid radiopaque materials comprise materials selected from thegroup consisting of barium sulfate, bismuth trioxide, bismuth carbonate,and one or more powdered metals selected from the group consisting oftungsten, tantalum, gold, ruthenium, rhodium, osmium, iridium,palladium, platinum, rhenium, and their mixtures. These materials areoften milled to a very fine particle size, a size that may be suspendedin a fluid filler material such as those shown just above.

Placement of the listed metallic materials, as well as other radiofrequency absorbing materials such as various iron oxides or hydroxides,graphite, and amorphous carbon also allows the filler material to beused as a “target” for radio frequency loading or heating. That is tosay that a filler containing such radio frequency absorbing materialswill, when subjected to a suitable radio frequency emission, absorb theenergy and become heated. Low frequency radio-energy (e.g., 400-550kHz.) and microwave radio energy (900 MHz. to 2.75 GHz.) are commonlyused on the human body and are suitable in this service although themicrowave is much more efficient.

Such internal electromagnetic heating may be used in a variety ofprocedures depending variously upon the placement of the bladder in thebody and the value of the resulting elevated temperature, to warm tissuein the manner of an immune response, to coagulate blood or collagenoustissue or other tissue, to desiccate tissue, to ablate tissue, or evento necrose or to carbonize tissue. The list of maladies in whichelevated localized temperatures are used is quite extensive. Forinstance, elevated localized internal temperatures are used in thetreatment of tumors and cysts and endometriosis and in sterilization ofmales and females, in the controllable production of emboli forocclusion of aneurysm, for remodeling of tissue (via shrinkage, bulking,reshaping or the like) in reforming female uro-genital structures, etc.Such higher temperatures may be used in curing biologic adhesives suchas the polycyanoacrylates (PCA) with or without accelerators orcatalysts. Although the level of power required and the frequency of theradio waves must be determined by the designer of a device according tothe teachings here, where the filled bladder is designed for aparticular treatment, such calculations and experiments are readily madeand require but modest work.

As may be apparent, the radio energy is applied to the filler within thebladder using appropriate antenna placed inside or outside the body.

Finally, the filler material may contain bioactive, chemi-active, orradioactive compounds as desired in conjunction with the desiredtreatment.

The invention has been described in terms of examples. It is our intentthat the various physical components found and shown with regard tothose examples be combined in the ways that would be used by one ofordinary skill in the art to fill out a specific design.

What is claimed is:
 1. An inflatable, expandable implant suitable forimplantation in a human body, comprising: a bladder comprising asubstantially non-elastic bladder wall defining a volume and having atleast one bladder wall opening for introduction of filler material; andan elastic bladder wall defining a volume and having at least onebladder wall opening for introduction of the filler material.
 2. Theimplant of claim 1, further comprising at least one closure for each ofthe bladder wall openings for maintaining the filler material within thevolume after introduction of the filler material into the volume.
 3. Theimplant of claim 1, where the substantially non-elastic and elasticbladder walls comprise fabrics selected from the group consisting ofwoven fabric and non-woven fabric.
 4. The implant of claim 1, where thesubstantially non-elastic bladder wall comprises at least one memberselected from the group consisting of polyethyleneterephthalate,polyvinylchloride, polyurethanes, polyolefins, polyamides, andfluoropolymers.
 5. The implant of claim 1, where the substantiallynon-elastic bladder wall comprises at least one fluoropolymer selectedfrom the group consisting of polytetrafluoroethylene,poly(ethylene-chlorofluoroethylene-), poly(fluorinated ethylenepropylene), polyperfluoroalkoxy, polychlorotrifluoroethylene,polyvinylfluoride, polyvinylidenefluoride, and expandedpolytetrafluoroethylene.
 6. The implant of claim 1, where thesubstantially non-elastic bladder wall comprises expandedpolytetrafluoroethylene.
 7. The implant of claim 1 further comprisingthe filler material.
 8. The implant of claim 7 wherein the fillermaterial is a filling liquid.
 9. The implant of claim 8 wherein thefilling liquid is selected from the group consisting of water, saline,and biocompatible liquids.
 10. The implant of claim 7 wherein the fillermaterial contains bioactive or chemi-active material.
 11. The implant ofclaim 7 wherein the filler material comprises a reactive mixture adaptedto react within the bladder volume.
 12. The implant of claim 7 whereinthe filler material comprises a member selected from the groupconsisting of elastic solids, viscoelastic solids, viscoelastic liquids,viscoelastic liquids comprising gel microparticles, viscous liquids, andtheir precursors.
 13. The implant of claim 7 wherein the filler materialcomprises a copolymer of a first member selected from the groupconsisting of poly(ethylene glycol), poly(ethylene oxide), poly(vinylalcohol), poly(ethylene-co-vinyl alcohol), poly(acrylic acid),poly(ethylene-co-acrylic acid), poly(ethyloxazoline), poly(vinylpyrrolidone), poly(ethylene-co-vinyl pyrrolidone), poly(maleic acid),poly(ethylene-co-maleic acid), poly(acrylamide), and poly(ethyleneoxide)-co-poly(propylene oxide) block copolymers and a second memberhaving a strong nucleophile selected from the group consisting of athiol or a group containing a thiol.